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- 2026-04-08 03:35:27
- Company
- NMOSD drug Enspryng can be prescribed at general hospitals
- by Eo, Yun-Ho Mar 18, 2024 05:50am
- Enspryng, a new drug for neuromyelitis optica spectrum disorder (NMOSD) is landing in general hospitals in Korea. According to industry sources, Roche Korea's Neuromyelitis Optica Spectrum Disorder (NMOSD) drug Enspryng (satralizumab) has passed the drug committees (DCs) of tertiary hospitals including Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, as well as medical institutions including the National Cancer Center, Chonnam National University Hospital, and Chungnam National University Hospital. In addition, the drug can be prescribed in an increasing number of medical institutions that inserted the drug code through emergency DC meetings to prescribe Enspryng. As such, the drug’s prescriptions have been increasing steadily after being granted reimbursement in December last year. Enspryng was approved in Korea in the first half of 2021, after which the company submitted an application for its reimbursement in the second half of 2022. However, due to its high price, the company faced considerable difficulties in setting its reimbursement standards and financial sharing plans. The company had first adopted the strategy of accepting the weighted average price (WAP) of its alternative, AstraZeneca’s ‘Soliris (eculizumab),’ but due to a delay in Soliris’s reimbursement listing process for NMOSD, the company turned to the pharmacoeconomic evaluation exemption track for its reimbursement. After switching to the PE exemption track, the agenda passed HIRA’s Drug Reimbursement Evaluation Committee in August and completed pricing negotiations with the NHIS in November of the same year. However, its reimbursement is currently limited to its use as a ‘fourth-line or later’ therapy. Currently, the immunosuppressant azathioprine is used as first-line maintenance therapy for NMOSD. If a patient fails treatment with azathioprine, mycophenolate, or rituximab is prescribed with reimbursement as second-line therapy. Both mycophenolate and rituximab are off-label drugs that do not have NMOSD indications. In other words, Enspryng can only be used as fourth or later-line therapy in patients who fail treatment with rituximab in the third-line. Therefore, it remains to be seen whether the company will seek to extend reimbursement for Enspryng after listing. Meanwhile, Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Policy
- Sotyktu, Adtralza set for reimbursement listing
- by Lee, Tak-Sun Mar 18, 2024 05:49am
- Sotyktu. Two drugs, plaque psoriasis drug 'Sotyktu (deucravacitinib)' and atopic dermatitis drug 'Adtralza (tralokinumab)' have completed the negotiation with the National Health Insurance Service (NHIS) and may soon be listed for reimbursement. Additionally, the upper price limit of Soliris (eculizumab) is expected to be reduced following the expansion of reimbursement for neuromyelitis optica. According to industry sources on the 15th, Sotyktu and Adtralza concluded negotiations with the NHIS to receive reimbursement. Sotyktu is the first TYK2 inhibitor to be approved in South Korea for treating adult patients with moderate to severe plaque psoriasis. It is administered orally once a day for convenience. The drug was approved by the Ministry of Food and Drug Safety (MFDS) last August and cleared the review by the Drug Reimbursement Committee of the Health Insurance Review and Assessment Service (HIRA) in December. BMS Pharmaceutical, the company for Sotyktu, agreed to the evaluation price suggested by the Drug Reimbursement Committee. Notably, the company accepted an amount below the standard for negotiation exemption, solely negotiating for the anticipated claim amount. BMS Pharmaceutical and Yuhan recently made a joint promotion agreement for Sotyktu. When the drug gets listed on reimbursement next month, Sotyktu will likely be distributed through the marketing network of Yuhan-BMS. Adtralza. LEO Pharma’s 'Adtralza' is a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13). Adtralza approval is expected to expand the treatment options for atopic dermatitis as Dupixent (dupilumab) is the only biologic available for treating the disease. Like Sotyktu, Adtralza is expected to be listed for reimbursement after one year of approval. It was approved last August and cleared for review by the Drug Reimbursement Committee in November Adtralza began negotiations with the NHIS in last November and it has recently come to an agreement. Currently reimbursed for atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH), Soliris is expected to receive approval for additional reimbursement for neuromyelitis optica spectrum disorder (NMOSD). Soliris is under pre-review by the HIRA. It is reported to be a high-priced new drug, valued at approximately KRW 500 million. Since 2015, the financial burden of the drug has been mitigated through Risk Sharing Agreements (RSA) but transitioned to regular listing in October 2019. Soliris. The company submitted the request for expanding Soliris’ reimbursement to neuromyelitis optica in 2021, but it took some time to be listed for reimbursement. After concluding negotiations with the NHIS, the coverage by reimbursement is expected to begin next month. With the reimbursement expansion, the current upper price limit of KRW 5,130,000 is expected to be reduced.
- Opinion
- [Reporter’s View] 'Tylenol,' no longer produced,
- by Lee, Hye-Kyung Mar 18, 2024 05:49am
- Twelve years have passed since the government desginated over-the-counter emergency medicines. On November 15, 2012, the government implemented 13 over-the-counter (OTC) emergency medicines, including antipyretic analgesics, gastrointestinal medicine, and patches. When designating 13 OTC emergency medicines, the government based its evaluation primarily on consumer ‘brand awareness,’ meaning medicines with high name recognigtion and a long history of use, allowing consumers to choose the brand. The current list of OTC emergency medicines includes Tylenol Tab 500 mg, Tylenol Tab 600 mg, Children's Tylenol Suspension, Brufen Syrup for Children, Pancol A Sol, Panpyrin-T Tab, Bearse Tab, Dr. Bearse Tab, Festal Gold Tab, Festal Plus Tab, Jeil Cool Pap, and Sinsin Pas Arex. Since the initial designation of OTC emergency medicine, the list has not been updated once. In July 2012, the Ministry of Health and Welfare (MOHW) stated they would make an interim evaluation after six months and re-organize the pharmaceutical items after a year. Additionally, if necessary, there can be a withdrawal of designation or additional designations according to the Pharmaceutical Affairs Act, which states that OTC emergency medicine can include ‘less than 20 items, not fixed to 13 items. However, the list still includes the drugs that can no longer be manufactured in South Korea as the manufacturing plant shutdown, and the government is reviewing on the withdrawal of those OTC emergency medicines for eight months. The Ministry of Food and Drug Safety (MFDS) approved discontinuances of ‘Children's Tylenol Tab 80 mg’ and ‘Tylenol Tab 160 mg’ on March 21, 2022. The reason for discontinuance is the manufacturing plant shutdwon due to relocation to overseas. Previously, the MOHW stated that despite the MFDS’s approval of withdrawal, they can not decide to withdraw OTC emergency medicines because the stocks are still in the market. As the stocks ran out in convenience stores last October, the MOHW has organized an expert advisory group. Two years have passed since two OTC Tylenol emergency medicines were voluntarily withdrawn. We hope that the expert advisory group will discuss not only the withdrawal of Tylenol from the list but also the designation of alternative medicines and the reorganization of the OTC emergency medicines list.
- Company
- Price nego for reimb of much-petitioned Enhertu complete
- by Eo, Yun-Ho Mar 18, 2024 05:49am
- The long journey of the petitioned anticancer drug ‘Enhertu’ if finally coming to an end. According to Dailypharm’s coverage, Daiichi Sankyo and AstraZeneca Korea recently completed drug pricing negotiations with the National Health Insurance Service (NHIS) for their antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhertu (trastuzumab deruxtecan) Barring any changes, the drug is expected to be covered from next month (April). After receiving approval for Enhertu in Korea in September 2022, the companies submitted a reimbursement application for the drug in December of the same year. Although the application passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee after re-deliberations, it took 8 months afterward for the agenda to pass the Drug Reimbursement Evaluation Committee in February. With 50,000 people signing a petition and the government being questioned on the reimbursement progress repeatedly by the National Assembly, both the government and the company would have had to carry a significant burden during reimbursement discussions. When considering the limited scope of freedom the company has with regard to the drug price, the fact that Enhertu’s reimbursement passed the DREC review this time implies that the government has set the ICER threshold at least KRW 50 million. What is encouraging is the speed with which the negotiations were concluded. Considering how the drug’s pricing negotiations began late last month, the parties had reached an agreement way before the given deadline (60 days). There were certainly challenges that needed to be overcome during negotiations. Even with the extraordinary ICER threshold granted for the drug, the company would have had limitations in accommodating the set standards. In addition to the government and pharmaceutical companies' best efforts, to some extent, the quick progress may also be influenced by the political pressure ahead of general elections. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1 Enhertu, which was petitioned by 50,000 people, was presented to the Health Insurance Policy Review Committee this month and will be listed in April.
- Company
- Hanmi’s Rolvedon tops KRW 73 bil in US sales
- by Son, Hyung-Min Mar 15, 2024 05:49am
- The U.S. sales of Rolvedon (Korean product name: Rolontis), a treatment for neutropenia discovered by Hanmi Pharmaceutical, surpassed KRW 70 billion last year. Assertio plans to conduct additional clinical trials and demonstrate a competitive edge. According to the reports by Assertio on the 13th, Rolvedon generated $11 million in Q4 sales last year, showing a 38% increase from the previous quarter. Rolvedon’s sales last year amounted to $55.6 million (approx. KRW 73 billion). Rolvedon is a novel anti-cancer drug discovered by Hanmi Pharm. In 2012, Hanmi Pharm transported Rolvedon technology to U.S. Spectrum. After Assertio acquired Spectrum in April last year, it secured the licensing of sales and development of Rolvedon and lung cancer therapy poziotinib. Asserito is a pharmaceutical company specializing in developing treatments for the central nervous system and inflammation. It owns indomethacin, a nonsteroidal anti-inflammatory drug, and simvastatin, an oral film formulation. After the acquisition of Spectrum, Assertio further strengthened its pipelines. Quarterly Rolvedon sales trend (Unit: $1 million). Since its release in the United States in October 2022, Rolvedon has recorded sales of $10 million within three months. After the product launch, 70 distributors purchased Rolvedon. It was then utilized by the top three community oncology networks, accounting for 22% of the clinic market share. It continued to show strong sales up to Q2 last year. Rolvedon generated sales of $15.6 million in Q1 last year, and in Q2, it recorded $21 million (approx. KRW 28 billion), an increase of 34.6% from the previous quarter. Rolvedon’s sales in Q3 last year slowed down since its launch. It recorded $8 million in Q3 last year, a decrease of 62% from the previous quarter. According to Assertio, the demand for Rolvedon after applying the reimbursement system was below expectations. Rolvedon became available on the U.S. public reimbursement list with a permanent reimbursement J-code of 'J1449' starting last April. However, the current reimbursement system is less favorable than when Rolvedon was launched. However, Rolvedon rebounded in Q4 last year, generating $11 million in sales. “Rolvedon’s rebound was made possible by maintaining the principle of Rolvedon pricing and employing an updated commercialization strategy,” Assertio explained. “Rolvedon is expected to generate over $100 million in sales by improving patient accessibility and securing new sales channels,” Assertio stated. They added, “We will continue to conduct a clinical study of same-day administration to implement a differentiated strategy.” Conventional treatments for neutropenia, such as Neulasta, can only be administered 24 hours after cancer therapy, thereby prolonging hospitalization. Assertio plans to gain a competitive edge with its strategy of Rolvedon's same-day administration method. The Phase 1 clinical trials for same-day administration of Rolvedon are being conducted in the United States.
- Policy
- Anticipated shortage of Merck’s fertility drug ‘Gonal-F’
- by Lee, Hye-Kyung Mar 15, 2024 05:49am
- Merck has announced that 300/450/900IU Gonal-F Pen are expected to be short in supply. The shortage of Merck’s 'Gonal-F Pen,' which is the world’s first recombinant follicle stimulating hormone (r-FSH), is expected. Merck has announced that three, 300/450/900IU, of the four volumes of Gonal-F Pen approved by the Ministry of Food and Drug Safety (MFDS) are expected to be short in supply. Currently, the 150IU volume is in stock. Gonal-F, a medication for treating infertility, was approved in South Korea in 2007, following approvals in Europe in 1995 and the United States in 1997. It is used in 100 countries worldwide. Due to temporary supply delays stemming from manufacturing plant schedule, domestic supply shortages are expected from the 15th. “We are taking all necessary measures to ensure a smooth supply of our products. Once production at the manufacturing plant resumes, domestic supply is expected to return to normal after April 30th,” Merck stated. Gonal-F is a self-injectable medication used in female fertility procedures to induce follicular maturation and ovulation. Produced using the FBM (Filled-by-mass) method, it reduces batch-to-batch variability from 20% in other infertility treatments to 2%. It is primarily used for anovulation disorders, such as polycystic ovary disease (PCOD), and for ovarian stimulation and ovulation induction in assisted reproductive technology (ART). The Gonal-F prefilled pen form simplifies self-injection by providing clear dosage and administration information, reducing the burden of self-injection with a quick administration time of approximately 5 seconds. In 2020, Gonal-F imports totaled approximately KRW 10 billion when combining the sales of three dosages: 300IU at $1,473,768, 450IU at $915,755, and 900IU at $5,002,681, according to the import performance data from the MFDS. “Treatments can be substituted with Gonal-F 150IU or recombinant human follicle-stimulating hormone (FSH), which is currently approved and marketed,” Merck stated, anticipating that the supply disruption would have a minimal impact. Besides Gonal-F Pen, another medicine that contains the active ingredient follitropin alpha is Yooyoung Pharm’s 'Bemfola Prefilled Pen,' which had an import report of $1,517,095 in 2022. Additionally, Merck’s FDA-approved 'Pergoveris' is available. Pergoveris contains the active ingredients follitropin alpha, recombinant human follicle-stimulating hormone (r-hFSH), and lutropin alfa, recombinant human luteinizing hormone (r-hLH). Pergoveris can be used to treat severe infertility in patients who have deficiencies in both follicle-stimulating hormone and luteinizing hormone.
- Policy
- Gov't will specify scope of expense report details disclosed
- by Lee, Jeong-Hwan Mar 15, 2024 05:49am
- The Ministry of Health and Welfare recently met with physician and pharmacist organizations and the pharmaceutical, biotech, and medical device industries to collect opinions on setting the ‘scope of disclosure of expense reports’ that are prepared to report the expenses legally paid by pharmaceutical and biotech companies and medical devices to doctors and pharmacists. At the meeting, doctors' and pharmacists' organizations and the pharmaceutical, biotech, and medical device industries expressed their opinions that disclosing too much detailed information, such as the names of doctors and pharmacists and medical institutions, could lead to privacy violations or leakage of trade secrets. After reviewing the submitted opinions and consulting with legal experts, the MOHW plans to hold another meeting with medical and pharmaceutical organizations and the pharmaceutical, biotech, and medical device industries next month to deliver the final scope of information that will be disclosed in the expense reports. An MOHW official explained so regarding the government’s expense report disclosure system at a meeting with the press corp. The expense report on economic interests is a system that creates and stores information on items legally provided by pharmaceutical companies, medical devices, distributors, etc. to doctors and pharmacists to improve transparency and self-regulation of drug and medical device transactions. The system was introduced to Korea in 2018 and is known as the 'K-Sunshine Act' after a similar law in the United States. The scope of disclosed information in expense reports in the pharmaceutical, bio, and medical device sectors is a hot topic in the healthcare industry. This is because the disclosed information can directly or indirectly affect the activities between doctors and pharmacists and companies depending on whether the names of doctors and pharmacists, names of medical institutions and pharmacies, and license numbers are included. The MOHW is pondering over disclosing the list of doctors and pharmacists. The MOHW explained that it is seeking advice from legal experts including law firms, as there is potential for legal disputes due to the clash of private and public interests as individual and corporate information is disclosed. Under the current law, 7 categories of economic benefits are allowed to be provided to healthcare providers: sample products, support for academic conferences, support for clinical trials, product presentations, discounts under pharmacy payment terms, post-marketing surveys of medical devices, and use for performance verification before purchase. The MOHW held a meeting with providers including the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Korea Medical Devices Industry Association, as well as the pharmaceutical, biotechnology, and medical device industries, to finalize the scope of the disclosed information on expense report on legitimate economic interests. At the meeting, the providers requested a conservative scope of disclosure, citing concerns about privacy violations and trade secret leaks. The ministry plans to deliver and finalize the scope of information disclosure, including whether to disclose the list of doctors, at a meeting in April after internal review and external legal advice. A MOHW official said, "For example, for conferences, only the amount supported and the name of the conference is disclosed in the expense report. For product briefings, the amount supported and the list of attending doctors are disclosed. "For medical devices, the list of doctors in charge without the amount supported is disclosed to obtain MFDS approval.” The official added, "We plan to disclose the amount of money spent to check the performance of medical devices. However, whether to disclose of the list of doctors will be finalized after internal discussions. If the pharmaceutical, biotech, and medical device industries submit their 2023 expense reports by June, the information will be disclosed on the HIRA’s website by the end of December.” “The Ministry of Health and Welfare will actively promote the disclosure of information about the expense reports by preparing pamphlets for conferences and other events to spread awareness.” Meanwhile, on December 29 last year, the MOHW first disclosed the results of a survey on expense reports on economic interest (expenses) legally provided to doctors and pharmacists in 2022 by pharmaceutical companies, and medical device distributors. At the time, a total of 11,889 pharmaceutical and medical device companies submitted data, of which 3,274 companies provided economic benefits. The amount of benefits provided amounted to KRW 808.7 billion in monetary value, and to 20.47 million items in terms of products.
- Company
- Sam Chun Dang seeks EMA approval for its Eylea biosimilar
- by Nho, Byung Chul Mar 15, 2024 05:48am
- Sam Chun Dang Pharm announced today that its European partner has simultaneously filed for approval of both vial and prefilled syringe formulations of its Eylea biosimilar (SCD411) in Europe. The application is notable as it is the first application filed in Europe following Korea for the prefilled syringe formulation. The application will undergo the EMA’s Centralised Procedure (CP). If the European Medicines Agency (EMA) reviews and approves the application, the drug will be approved simultaneously in more than 30 European countries. An official from Sam Chun Dang Pharm said, ‘The pre-filled syringe formulation is more difficult to develop than vials due to difficulty in developing the manufacturing process, including patent evasion and sterilization, but Sam Chun Dang Pharm focused all its capabilities on developing the prefilled product and was able to complete development and apply for approval before our competitors.” “We applied for the Centralized Procedure (CP) to shorten the approval period and quickly enter the market. The actual application was filed a long time ago, but it took some time for us to agree on whether to disclose the fact with our partners, which is why we disclosed it now." Sam Chun Dang Pharm filed for approval in Korea and Europe in March last year based on the final report of the Phase III clinical trial of its Eylea biosimilar and is in the process of negotiating supply contracts with partners in the U.S., Russia, and the Middle East.
- InterView
- “Solid position of JAK inhibitors despite ongoing concerns"
- by Eo, Yun-Ho Mar 15, 2024 05:48am
- Professor Seung Cheol Shim. JAK inhibitors, an 'oral drug' that initially gained attention in the field of autoimmune diseases, are now considered one of the treatment options. The first approved ‘Xeljanz (tofacitinib)’ has accumulated a ten-year prescription record. The fifth JAK inhibitor, ‘Jyseleca (filgotinib),’ is now available on the reimbursement listing. With their convenient oral administration, JAK inhibitors have emerged as favorable treatment options, providing an alternative to injectable anti-TNF inhibitors. In the medical field, JAK inhibitors are now considered a treatment option for patients with conditions such as rheumatoid arthritis and ankylosing spondylitis. “Various treatment options are now available for treating autoimmune diseases, including anti-TNF inhibitors and interleukin inhibitors. However, some patients are unresponsive to existing medicines,” Professor Seung Cheol Shim of the Division of Rheumatology at Chungnam National University Hospital stated. “JAK inhibitor, which blocks inflammatory signaling within the cell unlike biological inhibitors, can provide solutions to unmet needs,” he added. However, safety concerns remain an issue that needs to be addressed with JAK inhibitors. In 2021, JAK inhibitors faced issues related to cardiovascular side effects. The U.S. FDA issued warnings about the risks of heart disease, cancer, and other safety issues associated with JAK inhibitors. Similarly, the Ministry of Food and Drug Safety (MFDS) also distributed safety letters. Eventually, the FDA made a decision to include critical cardiovascular events, thrombosis, and mortality risks in boxed warning labels for JAK inhibitors. Although causality between the drug and adverse reactions has not been definitively proven, the safety concerns surrounding JAK inhibitors remain unresolved. “Due to these reasons, I still prefer anti-TNF inhibitors as the first-line treatment. It's not a matter of what's better. I have long experience prescribing anti-TNF inhibitors, and managing adverse reactions (such as tuberculosis) is also possible. However, while there may be hypotheses about JAK inhibitors, the exact cause remains unknown,” Shim explained. “Furthermore, considering the clear advantages of JAK inhibitors, they are often considered for relatively young patients with lower cardiovascular risks during their first medical examination,” Shim added. Some reimbursement criteria have yet to be addressed. While JAK inhibitors are expanding their indications to include atopic dermatitis, rheumatoid arthritis, and ankylosing spondylitis, there are undoubtedly still areas of uncertainty. “Due to special exemption of calculation provisions, patients who meet the reimbursement criteria have significantly reduced economic burdens. However, patients with seronegative rheumatoid arthritis still do not receive benefits. In the case of ankylosing spondylitis, reimbursement prescriptions are only possible for patients with confirmed bone damage. These issues need to be addressed,” Shim stated. The medical field has long complained about the issue of cross-medication between JAK inhibitors. “While cross-medication reimbursement is approved for ankylosing spondylitis, it is not approved for rheumatoid arthritis. The issue lies in the limited availability of data regarding JAK inhibitors in South Korea. More data on JAK inhibitors must be collected to expand reimbursement criteria,” Shim emphasized.
- Policy
- HIRA’s CDDC seeks to revise current regulations
- by Lee, Tak-Sun Mar 15, 2024 05:48am
- The current regulation that randomly selects members for each Cancer Disease Deliberation Meeting will be deleted. The measure was prepared to maintain consistency in the committee’s deliberations. In addition, the Korean Association for Lung Cancer will be added as a recommended organization given that lung cancer drugs are often on the agenda. The Health Insurance Review and Assessment Service issued a notice of the proposed amendments to the Operating Regulations for the Severe Disease Review Committee (Cancer Disease Review Committee, CDDC) on the 13th of this month. The amendments were made for the following reasons: ▲ to specify the legal grounds for establishing the committee in detail ▲ to update the committee's composition practice according to the occurrence of organizations with a low number of recommendations ▲ to change the method of selecting attendees due to the continuous occurrence of agendas for specific cancer types (to maintain consistency in deliberations by including members with continuum when organizing meetings) ▲ to amend the lack of the term of office clause for HIRA members ▲ and to strengthen expertise by adding organizations related to frequent agendas to the recommended organizations. In particular, the current random selection regulation will be removed to maintain the expertise and consistency of the committee members during meetings. Article 3, Paragraph 1 of the current regulations stipulates, "The committee shall consist of no more than 25 members randomly selected for each meeting.” However, since a variety of anticancer drugs are reviewed by the Cancer Disease Deliberation Committee, the committee decided to delete the reregulate as it may be difficult to establish consistent reimbursement standards while replacing members every time. A HIRA official said, “We are already flexibly adjusting the composition of the committee members to reflect the characteristics of the drugs, but decided to remove the regulation to maintain expertise and consistency in our deliberations.” Accordingly, the regulation will be changed to "consist of no more than 25 members, including 9 clinical experts, but may consider Appendix 2 with reference to the specialty and contents of each meeting’s agenda. Appendix 2 refers to the experts recommended by expert societies, and the Korean Lung Cancer Society has been added in the recent amendment. This is a reflection of the recent increase in the number of lung cancer treatments presented on the agenda. The composition of the committee will also be changed. The number of clinical experts recommended by the director will increase from 2 to 3, while the number of experts recommended by health-related organizations will decrease from 3 to 2. In addition, the number of reviewers for solid cancer and hematologic cancer drugs will be changed from 2 reviewers each to 2 reviewers. In addition, the wording of Article 14 regarding the disclosure of review results will be revised. Although the current regulation states that “the committee shall not disclose the results of deliberations,” when the disclosed information is deemed to negatively affect the public's right to receive reimbursement, the reimbursement policy of the Ministry of Health and Welfare, or when to harm the reimbursement order, the revised regulation leaves open the possibility of disclosure, by changing the phrase to “may not disclose the results of deliberations.” The opinion inquiry period for the proposed amendment will end on the 19th. Meanwhile, the 10th Cancer Disease Review Committee recently began its two-year term. The 10th committee consists of 40 members and is chaired by Professor Ho-Young Lim of the Samsung Medical Center.
